Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-01

Study Completion Date

2013-03-31

Brief Summary

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Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.

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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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IT opioids

Patients with IT pumps receiving IT opioids

No interventions assigned to this group

Systemic opioids

Patients taking oral or transdermal opioids for chronic pain

No interventions assigned to this group

Non-opioid management

Patients managing chronic pain without taking opioids

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Males or females greater than 18 years of age with legal decision making ability.
* Subjects receiving care at the Brigham and Women's Hospital Pain Management Center.
* Subjects must have a history of chronic pain \> 6 months and must have been a patient in the BWH Pain Center \> 6 months.

Exclusion Criteria

* Pain due to metastatic cancer or to cancer that is locally invasive
* Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen
* Evidence of psychosis or hospitalization for psychiatric illness during study
* Pregnancy at any time during the study
* Altered mental status that would make subject unable to complete outcome questionnaires
* Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No